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The company is voluntarily recalling four lots of Drospirenone and Ethinyl Estradiol Tablets, USP because of the possibility they may contain defective blister packs and incorrect tablet arrangements.
On March 4, 2019, FDA announced that Apotex Corp. is voluntarily recalling four lots of Drospirenone and Ethinyl Estradiol Tablets, USP because of incorrect packaging. The company states that the recalled lots may contain defective blister packs with incorrect tablet arrangements or an empty blister pocket.
Drospirenone and Ethinyl Estradiol Tablets, USP is used to prevent pregnancy. The package should contain 28 film-coated, biconvex tablets in the following order: 21 yellow color tablets, each containing 3 mg drospirenone (DRSP) and 0.03 mg ethinyl estradiol (EE), and 7 placebo white color tablets. This type of packaging error could result in a patient not taking a dose or taking a placebo instead of an active tablet. The company has not received any reports, as of March 4, of any adverse events or pregnancy.
The recalled product was distributed nationwide to wholesalers and distributers and was manufactured by Oman Pharmaceutical Products Co. LLC. Oman under subcontract from Helm AG, Nordkanalstrasse 28, Hamburg, 20097, Germany.